Containment system for encapsulating a sharp medical instrument

ABSTRACT

A containment system encapsulates a sharp medical instrument. The containment system includes a container having an upper end for insertably accommodating the medical instrument. The container supports a pair of liquid components of a two-part hardenable compound which are separated by a rupturable divider. The components are mixed upon rupture of the divider caused by insertion of the medical instrument thereinto. The hardenable compound thereby hardens around the medical instrument, quickly and permanently encapsulating the inserted instrument.

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to Provisional Application,Serial No. 60/225,874, filed on Aug. 17, 2000 and entitled “ContainmentSystem For Encapsulating A Sharp Medical Instrument”.

FIELD OF THE INVENTION

[0002] The present invention relates generally to a containment systemfor disposal of a sharp medical instrument such as a hypodermic needle.More particularly, the present invention relates to a containment devicewhich quickly and permanently seals, plugs and encapsulates an insertedneedle, making it unusable and allowing the safe disposal thereof.

DISCUSSION OF THE RELATED ART

[0003] The handling and disposal of used medical instruments,particularly sharp medical instruments such as hypodermic needles,suture needles, lancets, trocars, scalpel blades and the like is a majorproblem facing healthcare professionals. Blood-born pathogens can beeasily transmitted by inadvertent contact with the used medicalinstrument such as by accidental needle sticks.

[0004] In order to avoid such accidental needle sticks, especiallyimmediately after using the medical instrument, the healthcareprofessional will attempt to cover the needle with a protective cap orsheath so that the instrument can be safely transported for disposal.The provision for caps and sheaths affords some degree of protection,however many accidental needle sticks occur while trying to place thecap or sheath back on the needle in preparation for transport fordisposal.

[0005] In the absence of re-capping or re-sheathing, quite often theused medical instrument is transported uncovered to a sharps containerwhich ideally is located proximate to the site. The sharps containerholds several used medical instruments in a hard puncture-resistantpackage which is subsequently collected for final disposal. However,this still requires the healthcare professional to handle and transportthe unprotected needle after use. Also, the collected used instrumentsremain on site in the sharps container until collected for finaldisposal.

[0006] The art has seen many devices for capping, closing and sheathingused sharp medical instruments for disposal. Many of these devicessimply enclose the entire medical instrument, or at least the sharpportion thereof in a protective enclosure. Other of these devicesattempt to encapsulate or surround the used medical instrument with acomposition which hardens around the sharp portion of the instrument,providing permanent containment and protection.

[0007] One such encapsulation system is shown in U.S. Pat. No. 5,322,165where a two-part hardenable compound is provided in a container whichaccepts a sharp medical instrument such as a hypodermic needle. Thecontainer of the ′165 patent supports a hardenable resin such as acyanoacrylate ester and a filler of particulate matter in spacedseparation. The filler includes an accelerator which is used to speed upthe hardening of the resin. The resin and the filler accelerator areseparated by a rupturable partition such as thin glass. The used medicalinstrument, such as a needle, is inserted into the container, rupturingthe glass membrane between the two components, thereby causing thecomponents to come together and harden around the needle.

[0008] Another encapsulation system for a sharp object is depicted inU.S. Pat. No. 4,845,923 wherein a container holds a first liquidreactive agent and a porous foam impregnated with a second reactiveagent. A pierceable membrane separates the porous impregnated foam fromthe first reactive agent. Upon piercing the membrane, the first reactiveagent is absorbed by the foam which then, as a result of hardening,encapsulates the sharp object.

[0009] As may be appreciated, the length of time it takes for the resinand accelerator to react and harden around the needle is of particularimportance. If, upon insertion of the needle into the container, thehardening process takes too long, there is risk that the needle can beremoved from the container, thereby exposing the healthcare professionalto an increased risk of accidental needle stick. Further, if thecomponents in the container require some form of agitation to assurecomplete hardening, such as may be the case where one of the componentsis a particulate matter such as a filler, the subsequent mixingoperation by the healthcare professional may present additional risksor, as significantly, if done improperly, may result in incompletehardening around the inserted needle and failure to plug the needleitself.

[0010] It is, therefore, desirable to provide an improved containmentsystem for supporting a two-part hardenable compound which is quicklymixed so that hardening can occur upon simple insertion of the sharpmedical device into the container to harden around the needle as well asplug the needle making it unusable.

SUMMARY OF THE INVENTION

[0011] The present invention provides a containment system forencapsulating a sharp medical instrument. The containment systemincludes a container having an end for insertably receiving the sharpmedical instrument. The container supports a pair of liquid componentsof a two-part hardenable resin material. The two liquid componentsinclude a hardenable resin first part and a resin hardener second part,each of which are separated by a rupturable divider which is rupturedupon instrument insertion. The components are mixed upon rupture of thedivider and harden to encapsulate the inserted medical instrument.

[0012] In one particular embodiment of the present invention, thecontainer includes an open ended container base which accommodates oneof the pair of liquid components, and an open ended container cap whichinsertably receives the medical instrument and accommodates the other ofthe pair of liquid components. The cap is positioned and secured overthe open end of the base with the rupturable divider being positionedtherebetween. The rupturable divider may be a glass wafer which isshatterable upon instrument insertion.

[0013] The compounds may include a hardenable resin and a resinhardener. The hardenable liquid resin may be selected from a variety ofresins which can be cured rapidly (meth)acrylates, cyanoacrylates,vinyls, epoxies and combinations thereof. For example, anaerobicallycurable resins, polyurethane polyacrylate resins, epoxy resins,cyanoacrylates, vinyl resins, silicones, silicone-acrylate resins may beemployed. The liquid resin hardener may be selected in accordance withthe type of hardenable resin employed. For example, free radicalinitiators, metal catalysts, acidic or basic catalysts and/oraccelerators may be employed. For purposes of this invention, the term“liquid resin hardener” will include any material, such as initiators,catalysts, accelerators, and promoters, which when mixed with thehardenable resin causes the resin to harden.

[0014] In further embodiments, the rupturable divider may include abreak-away wall which is snap-fitted onto the container cap and isbroken away by instrument insertion.

[0015] In a method aspect of the present invention, a method ofencapsulating a sharp medical instrument is provided. The methodincludes inserting the instrument into a container supporting a pair ofliquid components of a two-part hardenable compound. The components areseparated by a rupturable divider. Upon inserting the instrument intocontainer, the divider is ruptured and the components become mixed so asto cause the compound to harden around the instrument.

[0016] In a further particular aspect of the present invention, acontainer for enclosing a medical instrument having a sharp extentcomprises a container housing having an upper chamber, a middle chamberand a lower chamber. The upper chamber has an upper end for insertablyreceiving the instrument and for accommodating a first component of atwo-component hardenable compound. The middle chamber accommodates asecond component of the two-component hardenable compound. A rupturabledivider is disposed between the upper chamber and the middle chamber,the divider being rupturable upon instrument insertion to cause thefirst and second components to mix in the middle chamber and hardenaround a portion of the inserted instrument. A penetrable wall isdisposed between the middle chamber and the lower chamber, the wallbeing penetrable by a sharp extent of the instrument, the lower chamberbeing configured to receive and accommodate the sharp extent of theinserted instrument.

BRIEF DESCRIPTION OF DRAWINGS

[0017]FIG. 1 is an exploded vertical section of one embodiment of thecontainment system of the present invention.

[0018]FIG. 2 is a vertical sectional showing of the assembledcontainment system of FIG. 1.

[0019]FIGS. 3, 4 and 5 are sectional showings of containment system ofFIG. 1, including two-part liquid encapsulate accommodated therein, withthe figures showing progressively the insertion of a needle thereinto.

[0020]FIG. 6 is a vertical section of a further embodiment of thecontainment system of FIG. 1.

[0021] FIGS. 7-10 are vertical sections of additional embodiments of thecontainment system of the present invention.

[0022]FIG. 11 is a schematic showing of a tray used to support aplurality of containment devices shown in FIGS. 1-10.

[0023]FIG. 12 is a perspective view of a further particular form of acontainer for encapsulating a sharp medical instrument in accordancewith the present invention.

[0024]FIG. 13 is a perspective vertical sectional view of the containerof FIG. 12.

[0025]FIG. 14 is a vertical sectional view of the container of FIG. 12.

[0026]FIG. 15 is a perspective view of an upper cup component of thecontainer of FIG. 14 for accommodating one component of a two-componenthardenable compound.

[0027] FIGS. 15(a) and 15(b) are perspective views of variations of theupper cup component of FIG. 15.

[0028]FIG. 16 is a vertical sectional view of the container of FIG. 12shown in encapsulating assembly with a hypodermic needle.

DETAILED DESCRIPTION OF THE INVENTION

[0029] The present invention provides a containment system for theencapsulation of a sharp medical instrument such as a hypodermic needle.The containment system is easy to use and quickly encapsulates theneedle after use, thus reducing the incident of accidental needle stickby making it non-reusable.

[0030] With reference to FIGS. 1 and 2, one embodiment of the presentinvention provides a containment assembly for supporting and separatingtwo liquid components of a two-part hardenable compound. A first liquidcomponent is supported in spaced separation from second liquidcomponent. In the present invention, first component may be a liquidhardenable resin of the type selected from the group consisting ofanaerobically curable resins, epoxy resins, cyanoacrylates, vinylresins, silicones, silicone-acrylate resins and combinations thereof. Asecond component may include a liquid resin hardener selected from thegroup consisting of free radical initiators, metal catalysts, acidic orbasic catalysts or combinations thereof. The two liquid componentsforming the liquid hardenable resin and the liquid resin hardener aremiscible. Thus, upon mixing the liquid hardenable resin with the liquidresin hardener, the liquid components rapidly harden, and, as will bedisclosed in further detail hereinbelow, completely encapsulate aninserted sharp medical instrument such as a hypodermic needle.

[0031] The containment assembly 10 preferably includes three assembledcomponents. A base 16 supports a liquid resin hardener 12 while a cap 18supports a liquid resin 14. A rupturable divider in the form of amembrane or wafer 20 is supported between cap 18 and base 16, so as tocontain hardener 14 in the cap and to separate resin hardener 12 fromliquid resin 14. As may be appreciated, alternatively, the base maysupport the resin while the cap supports the hardener.

[0032] While the components forming containment assembly 10 may takevarious shapes and configurations, base 16 is generally a cup-shapemember having a closed bottom surface 22 and an opposed open end 24,with a circumferential sidewall 26 extending therebetween. Base 16defines an interior 17 for accommodating liquid hardenable resin 12 atthe lower end thereof. The distal extent of sidewall 26 defines arim-like seat 30 for supporting rupturable wafer 20 thereon. Also, base16 includes an outwardly extending lip 31, which as will be described indetail hereinbelow, provides for securement of cap 18 thereto.

[0033] Cap 18 is generally an elongate member having an enlarged loweropen end 32 and an opposed upper end 34, closed by a transversepuncturable wall 36. An elongate circumferential sidewall 38 extendsbetween lower end 32 and upper end 34 of cap 18.

[0034] Base 16 and cap 18 may be formed of any suitably rigid material,preferably molded plastic which, with the exception of transverse wall36, is resistant to puncture by a sharp medical instrument such as ahypodermic needle. It is also preferable that base 16 and cap 18 beformed of a transparent or translucent material so as to permit viewingof the components of the two-part compound, as well as the insertion ofthe sharp medical instrument therein.

[0035] As shown in FIGS. 1 and 2, cap 18 is attachable to base 16, withwafer 20 being secured therebetween. The enlarged lower end 32 of cap 18fits in a frictionally secured relationship with the extending lip 31 ofthe upper end of base 16. By such securement wafer 20, seated on rim 30,is captively secured between base 16 and cap 18. While frictionalsecurement of cap 18 to base 16 is shown, other securement techniquessuch as interfitting snap rings and/or screw securement may also beemployed. Wafer 20 with cap 18 defines a cap interior 19 foraccommodating resin 14.

[0036] Wafer 20 is preferably formed of shatterable material, such asglass. As such, upon contact with the sharp medical instrument duringinsertion thereof, the glass wafer 20 will shatter. Shattering of wafer20 assures that the interior 19 of cap 18 is placed in communicationwith the interior 17 of base 16 so as to cause the liquid resin 14 toflow from interior 19 into interior 17 and mix with resin hardener 12 inbase 16. While shatterable glass is preferred, the present invention maybe employed with any rupturable membrane supported between cap 18 andbase 16.

[0037] Transverse wall 36, extending across and closing the upper end 34of cap 18, may be integrally formed therewith or may be formed by aseparate component placed therein. Transverse wall 36 is readilypuncturable by the insertion of a hypodermic needle or other sharpmedical instrument. The puncturability of transverse wall 36 is providedby the thinness of wall 36, where the wall is formed integrally with cap18. Where wall 36 is formed separately from cap 18, the puncturabilityof wall 36 may be provided by its thinness or by the particular materialfrom which it is formed, such as thin metal foil. Prior to puncturing,however, transverse wall 36 serves to enclose the interior 19 of cap 18,providing containment of liquid resin 14 therein.

[0038] Having described the components of containment assembly 10 of thepresent invention, its operation in encapsulating an inserted medicaldevice may now be described with respect to FIGS. 3-5. In thedescription hereinbelow, the inserted sharp medical device is shown as aneedle 40, such as a hypodermic needle. However, it may be appreciatedthat any other sharpened medical device may also be employed incombination with the containment assembly 10 of the present invention.

[0039] As shown in FIG. 3, after using needle 40, the needle may beinserted into the open upper end 34 of cap 18. The sharp point 42 ofneedle 40 punctures puncturable transverse wall 36. Due to the thinnessand/or material forming wall 36, the wall is in close contact withneedle 40 which may assist in providing a wiping action as the needle isinserted thereinto. The needle progresses until the sharpened tip 40makes contact with glass wafer 20.

[0040] As shown in FIG. 4, upon the contacting of tip 42 with glasswafer 20 and upon continued insertion, the needle shatters glass wafer20. The shattering of the glass wafer 20 causes an immediate opening ofthe passage between interior 19 of cap 18 and the interior 17 of base16. This places the liquid resin hardener 12 in communication with theliquid resin 14. Once in contact, and with the liquid hardenable resinand the liquid resin hardener being miscible, immediate mixing andhardening of the combined materials takes place. The hardening occurs asthe needle 40 is pushed fully into the base 16 until it approaches or isstopped by the bottom wall 22 thereof. The risk of puncturing the bottomwall is prevented by forming the base of a suitably rigid plastic.

[0041] Since the materials forming the compound are liquid, some of thecombined material 50 will actually flow into the hollow interior channelof needle 40. This results in plugging the interior channel renderingthe needle non-reusable. The admixing of the liquid hardened resin withthe resin hardener causes encapsulation of the needle 40 within base 16rapidly, and desirably in a matter of seconds. The needle 40 is therebypermanently encapsulated and contained within the containment assembly10, preventing removal of the needle therefrom. Such containmentprevents any occurrence of an accidental needle stick. The containmentassembly 10 with the needle permanently encapsulated therein may now besafely transported for disposal.

[0042] Useful hardenable resins include any liquid resin which whenadmixed with the liquid resin hardener cures in a sufficiently rapidtime to be commercially acceptable for the device of the presentinvention. Usually, an acceptable hardening time is about 20 seconds toabout 40 seconds. More desirably, the hardening time is about 20seconds. Useful resins include anaerobically curable resins,polyurethane polyacrylate resins, epoxy resins, cyanoacrylates, vinylresins, silicone resins, and silicone-acrylate resins. Combinations andcopolymers of such resin materials are also useful.

[0043] More specifically, useful anaerobically curable resins includethose based on mono- and poly(meth)acrylate monomers. Such resins aredescribed, for example, as U.S. Pat. Nos. 3,043,820 and 3,046,262 toLoctite Corporation, which are incorporated herein by reference.

[0044] Resin hardeners particularly useful with anaerobic curing resinsinclude solutions of metal salts. The use of salt solutions facilitatesthe mixing of the resin hardener with the hardenable resin to obtainrapid hardening. Virtually any transition metal salt solution may beemployed, but salt solutions of copper, iron, nickel and zinc are mostdesirable. Examples of useful copper salts include copper octonate andthe diketone salts of copper. Accelerators typically employed withanaerobic systems may also be incorporated in the resin hardenercomponent. Amines are frequently used as accelerators in compatibleorganic carriers, such as tetraethylene glycol esters. Amines may beeffectively combined with saccharin. Hydrazine derivatives andsulfonamides are also useful as accelerators. A description of varioususeful accelerators can be found in U.S. Pat. Nos. 3,203,941; 3,218,305;4,180,640 and 4,287,330 to Loctite Corporation.

[0045] Useful cyanoacrylate resins include those described in U.S. Pat.Nos. 2,784,215 to Joyner and 3,742,018 to Loctite which are incorporatedherein by reference. These resins typically employ amines, thiols, orbenzothiazole sulfenamide derivatives as resin hardeners, as describedin U.S. Pat. Nos. 3,742,018 and 3,836,377, also incorporated herein byreference.

[0046] Epoxy resins useful in the present invention includes thosedescribed in Epoxide Resins and Their Formulations, Plastics forElectronics, 2 ^(nd) Edition, Edited by Martin Gossey, AcademicPublisher (1999). Typical resin hardeners for epoxies, such as amines orthiol compounds may be employed.

[0047] The relative proportions of the two parts of various curablecompositions may be chosen to ensure rapid cure. For example, in caseswhere epoxy compositions are employed, generally the resin and hardenercomponents are admixed in approximately equimolar proportions. Ininstances where anaerobic compositions or cyanoacrylate compositions areemployed, amounts of about 0.05 to about 1 gram of resin is generallyused for every 0.05 to about 0.025 grams of the resin hardener.Conventional proportions of resin to resin hardener may be employed,depending on the particular

[0048] Referring now to FIG. 6, further embodiment of the containmentassembly 10 of the present invention is shown. Containment assembly 60includes a base 62 which supports hardenable resin and a cap 64 whichsupports the liquid resin hardener. It should be understood that, in thealternative, base 62 may support the hardener and cap 64 may support theresin. Base 62 is generally a cup-shaped member having a closed bottomsurface 66 and an open upper end 68 with a cylindrical side wall 70extending therebetween. In the present embodiment, cap 64 is alsogenerally cup-shaped, having an open upper end 72, a closed bottom wall74, and a side wall 76 extending therebetween. In the presentembodiment, bottom wall 74 may be formed by a shatterable material suchas glass, or shatterable plastic which is easily shattered upon needleinsertion as described above with respect to the embodiment of FIGS.1-5.

[0049] Also, in order to assure that inserted needle contacts theshatterable bottom wall 74, side wall 76 includes a conical wall portion76. The conical shape of wall portion 76 helps guide the inserted needletowards the shatterable bottom wall 74, which is generally positioned atthe apex thereof. To further assure proper contact between bottom wall74 and the inserted needle, the bottom wall includes an upwardlyextending annular ridge 75. Ridge 75 accommodates the needle as it isinserted. Further, in order to prevent the needle from prematurelypuncturing side wall 76, the cup-shaped cap 64 is formed of rigidplastic which resists needle puncture.

[0050] Cap 64 is inserted in position within the interior 71 of base 70,and includes a radially extending annular lip 78 which sits atop arim-like seat 73 adjacent to the open upper end 68 of base 62. Thesecurement of cap 64 to base 62 may be by frictional engagement or maybe provided by other mechanical securement techniques such as asnap-fit. The engagement of lip 78 with seat 73 may be established suchthat a seal is provided therebetween.

[0051] The embodiment shown in FIG. 6 operates in a substantiallysimilar manner to the embodiments shown in FIGS. 1-5 whereuponshattering of the bottom wall 74, the liquid resin hardener is placed inimmediate communication with the hardenable resin. The extremely miscivenature of the components provides for hardening around the insertedinstrument.

[0052] Referring now to FIG. 7, a further embodiment of the presentinvention is shown. Containment assembly 80, shown in FIG. 7, includes abase 82 referred to as a lower reservoir and a cap 84 referred to as anupper reservoir which are substantially identical to those shown anddescribed with respect to FIG. 6. The bottom wall 86 of cap 84 is formedof a separate member which is attached to the conical portion 89 of sidewall 88 by a releasable snap fit. In the present illustrativeembodiment, bottom wall 86, which is itself conical in shape, includesan outwardly extending annular rib 90 which is snap-fitted into acorresponding groove 92 at the distal end of side wall 88. The rib andgroove snap-fit arrangement between bottom wall 86 and side wall 88provides for releasable securement thereof. Upon insertion of themedical instrument, bottom wall 86 is detached from side wall 88 so asto place the components respectively contained in base 82 and cap 84 inimmediate communication. As with the embodiment of FIG. 6, the side wall88 is formed of rigid plastic to assure that the inserted instrument isguided toward conical bottom wall 86 so as to effect detachment thereof.

[0053] As shown particularly in the embodiment of FIG. 7, cap 84 mayinclude a puncturable transverse covering 95 which encloses the interiorof cap 84. Covering 95 functions similar to transverse wall 36 of theembodiment of FIGS. 1-5.

[0054]FIG. 8 shows a further embodiment of the present invention whichis substantially similar to the embodiment shown in FIG. 7 having a base91 and cap 93. However, in the embodiment shown in FIG. 8, bottom wall97 is a generally flat member having an internally directed annulargroove 98 which is attachable to an outwardly extending annular rim 99on the side wall 95 of cap 93. As with the embodiment of FIG. 7,insertion of the medical device serves to detach bottom wall 97 from theside wall so as to place the respective component in communication.

[0055] With respect to FIG. 9, an additional embodiment of the presentinvention is shown. This embodiment, which is substantially similar tothe embodiments of FIGS. 6-8, includes a base 100 and a cap 102. Cap 102has a sidewall 106 defining at the bottom thereof, and an opening 103.Opening 103 is fitted with a releasable plug 104, which may be attachedto the circumferential inner edge of opening 103 by inwardly directeddetents 108. The plug 104, which may be formed of impenetrable plastic,is dislodged from the sidewall 106 upon instrument insertion so as toallow communication between the respective materials held in the cap andthe base.

[0056] The concept of the funnel or conical shape may be practiced withan embodiment of the invention similar to that shown in FIGS. 1-6.

[0057]FIG. 10 shows a further embodiment of the invention where a base116 and a cap 118 are separated by a glass wafer 120. The cap 118 mayinclude a funnel or conically shaped interior cavity 117. Similarly,base 116 may include a conically shaped upper interior section 119 whichserves to funnel the contents of cap 118 to the bottom of the base 116after glass wafer 120 is shattered.

[0058] In a typical laboratory or other medical setting, it is oftennecessary to use multiple needles at one time. The present inventioncontemplates placing or arranging plural containment assembly of thetypes shown in FIGS. 1-9 in a mutually supported array.

[0059] As an example, the containment assemblies may be held in a 10×10arrangement in a tray 150 shown in FIG. 11. Tray 150 includescompartments 152 which may each support one containment assembly. As maybe appreciated, other number arrays may also be employed. Further, othertechniques may also be used in supporting plural containment assembliesin a grid-like array.

[0060] Referring now to drawings FIGS. 12, 13 and 14, there is shown aparticular arrangement of a container 200 for encapsulating a hypodermicneedle. In this particular arrangement, container 200 is athree-component structure, comprising a container housing 202, a firstcup 204 and second cup 206. While each of the housing 202, first cup 204and second cup 206 is formed of molded plastic, it should be appreciatedthat other materials suitable for encapsulation purposes may be used.

[0061] Container housing 202 is of generally elongate, vial-likeconfiguration having a closed lower end 208 and an open upper end 210and an interior space 212. In one form of the housing configuration asshown particularly in FIGS. 12 and 13, the lower end of the housing 202tapers downwardly to a narrowing interior space toward the closed end208 while the upper end of the housing 202 flares outwardly to anexpanding interior surface toward the upper end 210. Adjacent the upperend of the housing 202 a circumferential recess 214 is provided forreceipt therein of the first cup 204, as will be described.

[0062] First cup 204 comprises sidewalls 216, a lower wall 218 and anopen upper end 220. First cup 204 is particularly formed to have atapering configuration narrowing toward the lower wall 218 and isadapted for insertion into the flared upper end of container housing 202as shown. First cup 204 is formed to have an outwardly extending flange222 that is particularly configured to be received in interference fitin housing recess 214.

[0063] In assembly with the housing 202, first cup 204 is disposedtherein such that lower wall 218 is axially spaced from the closed end208 defining thereby a lower chamber 224 for receipt therein of thesharp extent of a hypodermic needle as will be detailed. First cup 204further defines in assembly with the container housing 202, a middlechamber 226. Middle chamber 226 is adapted to accommodate therein afirst component of a two-component hardenable compound. In onearrangement, a liquid resin 14 of the type described herein isaccommodated in middle chamber 226 of first cup 204. Lower wall 218 offirst cup 204, while supporting the liquid resin 14 therein, is formedto be penetrable by the sharp extent of a hypodermic needle or othersharp object for receipt therethrough. While some seepage of compoundmay occur through the lower wall 218, it is intended that the hardenablecompound be substantially retained in the middle chamber 226. First cup204 is further formed at its upper end 220 to have a circumferentialrecess 228 for receipt therein of the second cup 206.

[0064] Referring now also to FIG. 15, the details of second cup 206 aredescribed. Second cup 206 is of generally cylindrical configurationhaving circumferential side walls 230, a rupturable bottom wall 232 andan open upper end 234. Second cup 206 further includes an outwardlyprojecting circumferential flange 236 particularly configured forinterference fit with recess 228 of first cup 204. It should beappreciated that while assembly of the first cup 204 in housing 202 andthe assembly of the second cup 206 in the recess of the first cup 204are described as being in interference fit, other suitable techniquesfor assembling these components may be used within the context of theinvention. In assembly with the first cup 204 and the housing 202, thesecond cup 206 defines an upper chamber 238 that particularlyaccommodates a liquid resin hardener 12, of the type described herein.It should be appreciated that while a liquid resin 14 is shown anddescribed as being accommodated in middle chamber 226 and a liquid resinhardener 12 is described as being contained in upper chamber 238, theresin 14 and hardener 12 may be reversed. A pierceable foil lid 240 isprovided over the upper chamber 238 to hold the liquid resin hardener 12therein.

[0065] In assembly, the bottom wall 232 of the second cup 206 isdisposed above the middle chamber 226. In one particular aspect, thebottom wall 232 is formed to have a series of radially projectingweakened score lines 242 that are adapted to break upon the insertion ofthe sharp extent of an object to be encapsulated in the container 200.

[0066] In another form of the second cup 206 a as shown in FIG. 15(atherupturable bottom wall 232 a formed to have a rupturable hinged door244. Hinged door 244 in one particular arrangement, is rectangular andis defined by three weakened score lines 245 forming three edges of thehinged door 244 and one non-scored edge defining a hinge for door 244.Upon insertion of the sharp extent of an object such as a hypodermicneedle to be encapsulated, the weakened score lines 245 are adapted tobreak open and the door 244 is rotatably openable about the non-scorededge which effectively provides a flexible hinge.

[0067] A further example of the second cup 206 b is illustrated withreference to FIG. 15(b). The bottom wall 232 b is provided with a plug246 that is adapted to fully break and separate from the rupturablebottom wall 232 b upon insertion of the sharp extent of the object to beencapsulated. Having described three particular configurations of arupturable bottom wall of the second cup 206, it should be appreciatedthat other variations may be made within the contemplated scope of theinvention.

[0068] Turning now to FIG. 16, the encapsulation of a hypodermic needleby the container of the present invention is described. Hypodermicneedle 248 comprises a hub 250 and an elongate sharp extent 252. Afterassembly of the first cup 204 and second cup 206 with container housing202 as described herein, the hypodermic needle is protected as follows.The sharp extent 252 first pierces through foil lid 240 and then throughthe rupturable bottom wall 232 of the second cup 206. Upon rupturing ofthe bottom wall 232, the liquid resin hardener 12 flows under gravitycompletely out from the upper chamber 238 into the middle chamber 226wherein it mixes with the liquid resin 14 to form hardenable compound254. Insertion of the hypodermic needle 248 continues with the sharpextent 252 penetrating through the lower wall 218 of the first cup 204until the hub 250 lies substantially within the middle chamber 226. Oncethe hub is fully disposed in middle chamber 226, the compound 254hardens around the hub 250 for suitable encapsulation. The sharp extent252, having penetrated through lower wall 218, projects into the lowerchamber 224 wherein it is completely surrounded within the housing 202and protected thereby. As described herein, the encapsulated syringesmay be deposited in a tray or the like for suitable transport anddisposal.

EXAMPLES

[0069] Example 1 is an example of an anaerobically curable two-partcomposition useful in the present invention. Part 1 and Part 2 of thecompositions are set for the below in weight percent based on the totalweight of each part.

Example 1

[0070] Part 1 Components (Resin) Wt % Poly(ethyleneglycol)dimethacrylate 79.32 Hydroxy methacrylate 10 Acrylic acid 61,4-Naphtaquinone 0.01 Pentasodium diethylenetriamine pentaacetic acid(PTDA) 0.07 Deionized water 0.2 Propylene glycol 0.6 100%

[0071] Part 2 Components (Liquid Hardener) Wt % 2-Ethylhexonic acid 29.0Copper carbonate 3.5 Poly (ethylene glycol) 200 Di (2-ethyl hexoate)57.5 Tri butyl amine 10 100%

[0072] About 0.5 to about 1.0 grams of part 1 of the anaerobiccomposition were placed in the cap of the inventive device. About 0.05to about 0.025 grams of part 2 (resin hardener) of the anaerobiccomposition were placed in the base. The barrier of the present devicewas then removed, permitting each of the parts to be combined andrapidly cure around the needle inserted therein. The curing time waswithin the range of about 20 to about 40 seconds.

[0073] Example 2 demonstrates a cyanoacrylate composition used in thepresent invention. The cyanoacrylate composition was formulated into atwo-part composition, each of the parts being described in percentweight of the individual parts.

Example 2

[0074] Part 1 Components (Resin) Wt % Ethyl cyanoacrylate monomer 99.899Boron trifluoride 0.001 Hydroquinone 0.100 100%

[0075] Part 2 Components (Liquid Hardener) Wt % N,N′-Dimethylp-toluidine 5.0 Poly(ethylene glycol)dimethacrylate 95.0 100%

[0076] Part 1 was placed in the cap of the inventive device in an amountof about 0.5 grams. Part 2 was placed in the base of the device inamounts of about 0.025 grams. The barrier was removed, permittingcombination of Part 1 and Part 2 and subsequent curing to fullyencapsulate the needle therein.

[0077] Example 3 demonstrates a cyanoacrylate composition used in thepresent invention. The cyanoacrylate composition was formulated into atwo-part composition, each of the parts being described in percentweight of the individual parts.

Example 3

[0078] Part 1 Components (Resin) Wt % Ethyl cyanoacrylate monomer 94.898Polymethyl Methacrylate 5.000 Boron trifluoride 0.002 Hydroquinone 0.100100%

[0079] Part 2 Components (Liquid Hardener) Wt % Glycerol Triacetate 93.0N-Oxydiethylene Benzothiazole-2-Sulfenamide 7.0 100%

[0080] Part 1 was placed in the cap of the inventive device in an amountof about 0.5 grams. Part 2 was placed in the base of the device inamounts of about 0.025 grams. The barrier was removed, permittingcombination of Part 1 and Part 2 and subsequent curing to fullyencapsulate the needle therein.

[0081] In any of the Examples 1-3 set forth herein, the Part 1 (Resin)and the Part 2 (Liquid Hardener) may be placed in either the cap or thebase of the encapsulant container.

[0082] The invention being thus described, it will be evident to thoseskilled in the art that the same may be varied in many ways. Suchvariations are not to be regarded as a departure from the spirit andscope of the invention and all such modifications are intended to beincluded within the scope of the claims.

What is claimed is:
 1. A containment system for encapsulating a sharpmedical instrument comprising: a container having an end for insertablyreceiving said medical instrument, said container supporting a pair ofliquid components of a two-part hardenable compound separated by arupturable divider, said components being mixed upon rupture of saiddivider by said insertion of said medical instrument thereinto.
 2. Acontainment system of claim 1, wherein said container further includesan open ended container base containing one of said pair of liquidcomponents, and an open ended container cap for insertably receivingsaid medical instrument and containing the other of said pair of liquidcomponents, said cap being positioned over said open end of said basewith said rupturable divider positioned therebetween.
 3. A containmentsystem of claim 2, wherein said container cap further includes apuncturable cover closing said open end thereof for receiving saidmedical instrument upon said insertion.
 4. A containment system of claim3, wherein said base contains a hardenable resin and wherein said capcontains a resin hardener.
 5. A containment system of claim 3, whereincontainer cap is cup-shaped and is inserted within said container base.6. A containment system of claim 5, wherein said cup-shaped cap includesa side wall and a breakaway bottom wall forming said rupturable divider,said side wall having a wall thickness resisting puncture by saidinserted instrument.
 7. A containment system of claim 3, wherein saidrupturable divider includes said bottom wall being detachable from saidside wall upon instrument insertion.
 8. A containment system of claim 3,wherein said rupturable divider is shatterable glass.
 9. A containmentsystem of claim 4, wherein said hardenable resin is selected from thegroup consisting of anaerobically curable resins, cyanoacrylates, vinylresins, epoxy resins, silicone resins, silicone-acrylate resins andcombinations thereof.
 10. A containment system of claim 9, wherein saidresin hardener is selected from the group consisting of initiators,metal catalysts, acidic catalysts, basic catalysts and accelerators andcombinations thereof.
 11. A container for enclosing a sharp medicalinstrument comprising: a container base having an open upper end foraccommodating a first component of a two component hardenable compound;a container cap positioned over said open upper end of said base andinsertably receiving said instrument, and for accommodating a secondcomponent of said two component hardenable compound; and a rupturabledivider positioned between said cap and said base for maintainingseparation between said first and second components, said divider beingrupturable upon said instrument insertion to cause said first and secondcomponents to mix and harden around said inserted instrument.
 12. Acontainer of claim 11, wherein said cap has an opposed open lower endclosed by said rupturable divider.
 13. A container of claim 11, whereinsaid cap is snap fitted over said base.
 14. A container of claim 13,wherein said container cap is a generally cup-shaped member insertableinto said container base, said cup-shaped member having a side wall anda breakaway bottom wall forming said rupturable divider, said side wallhaving a wall thickness resisting puncture by said inserted medicalinstrument.
 15. A container of claim 14, wherein said base is attachedto said side wall by a releasable snap fit.
 16. A container of claim 13,wherein said rupturable divider is a glass wafer supported between saidcap and said base.
 17. A container of claim 11, wherein said componentsof said two component hardenable compound are mutually miscive liquids.18. A container of claim 11, wherein said first component is ahardenable resin selected from the group consisting of anaerobicallycurable resins, cyanoacrylates, epoxy resins, vinyl resins, siliconeresins, silicone-acrylate resins and combinations thereof.
 19. Acontainer of claim 18, wherein said second component is a resin hardenerselected from the group consisting of radical initiators, metalcatalysts, acid catalysts, basic catalysts and accelerators andcombinations thereof.
 20. A container of claim 11, wherein said upperend of said container cap is closed by a puncturable cover.
 21. A methodof encapsulating a sharp medical instrument comprising the steps of:inserting said instrument into a container supporting a pair of liquidcomponents of a two-part hardenable compound separated by a rupturabledivider, said components being mixed upon rupture of said divider duringinsertion of said instrument to cause said compound to harden aroundsaid instrument.
 22. A method of claim 21, further including the step ofshattering a glass wafer forming said rupturable divider upon saidinserting step.
 23. A method of claim 21, further including the step ofbreaking away a portion of a wall defining said divider.
 24. A method ofclaim 21, wherein one part of said two-part hardenable compound is ahardenable resin and the other part as a resin hardener.
 25. A containerfor enclosing a medical instrument having a sharp extent, comprising acontainer housing having an upper chamber, a middle chamber and a lowerchamber, said upper chamber having an upper end for insertably receivingsaid instrument and for accommodating a first component of atwo-component hardenable compound, said middle chamber accommodating asecond component of said two-component hardenable compound, a rupturabledivider disposed between said upper chamber and said middle chamber,said divider being rupturable upon said instrument insertion to causesaid first and second components to mix in said middle chamber andharden around a portion of said inserted instrument, a penetrable walldisposed between said middle chamber and said lower chamber, said wallbeing penetrable by a sharp extent of said instrument, said lowerchamber being configured to receive and accommodate the sharp extent ofsaid inserted instrument.
 26. A container according to claim 25, whereinsaid middle chamber is defined by a first cup received in said containerhousing, said first cup having side walls and a lower wall, and an openupper end, said lower wall defining said penetrable wall.
 27. Acontainer according to claim 26, wherein said container housing isgenerally elongate and includes a closed lower end opposite said openupper end, said first cup being disposed in said container housing suchthat said lower wall and said housing closed end bound said lowerchamber.
 28. A container according to claim 27, wherein said containerhousing tapers toward said lower closed end and flares outwardly towardsaid upper open end.
 29. A container according to claim 28, wherein saidfirst cup tapers toward said lower wall and is received in said housingflared portion.
 30. A container according to claim 27, wherein saidupper chamber is defined by a second cup received in said containerhousing, said second cup having side walls and a bottom wall, and anopen upper end, said bottom wall defining said rupturable wall.
 31. Acontainer according to claim 30, wherein said second cup is disposedrelative to said first cup such that said bottom wall of said second cupand said lower wall of said first cup bound said middle chamber.
 32. Acontainer according to claim 30, wherein said rupturable wall comprisesa plurality of weakened score lines in said bottom wall that are adaptedto break open upon insertion of said sharp extent of said instrument.33. A container according to claim 30, wherein said rupturable wallcomprises a breakable hinged floor in said bottom wall including aplurality of weakened score lines and a flexible hinged portion, saidscore lines being adapted to break upon insertion of said sharp extentof said instrument, with said floor being hingedly openable as a resultthereof.
 34. A container according to claim 30, wherein said rupturablewall comprises a plug that is separable from said bottom wall uponinsertion of said sharp extent of said instrument.
 35. A containeraccording to claim 30, wherein said first cup, said second cup and saidcontainer housing are assembled in interference fit.
 36. A containeraccording to claim 30, wherein said second cup comprises a pierceablefoil sealing lid disposed over said upper chamber.
 37. A container forenclosing a hypodermic needle supported by a hub, comprising: anelongate container housing having an interior space, a lower closed endand an upper open end, said interior space adjacent said closed end ofsaid housing defining a first chamber; a first cup having side walls, abottom wall and an upper opening and defining a second chamber therein,said first cup being received in said upper open end of said housingwith said bottom wall communicating with said first chamber, said secondchamber configured to accommodate a first component of a two-componenthardenable compound; a second cup having side walls, a lower wall and anupper opening and defining a third chamber therein, said second cupbeing received in said upper open end of said housing adjacent saidfirst cup, the lower wall of said second cup communicating with saidsecond chamber, said third chamber configured to accommodate a secondcomponent of said two-component hardenable compound; said lower wall ofsaid second cup being rupturable upon insertion of said hypodermicneedle into said housing to cause said first and second components tomix and harden substantially in said second chamber; and said bottomwall of said first cup being penetrable upon insertion of saidhypodermic needle to allow said needle to pass therethrough and beaccommodated within said first chamber, with said hub being accommodatedin said second chamber for encapsulation by the hardening of saidcompound therearound.
 38. A container according to claim 37, furtherincluding a cover disposed over said third chamber.
 39. A containeraccording to claim 38, wherein said cover comprises a pierceable foilsealing lid.
 40. A containment system for encapsulating a sharp medicalinstrument comprising: means for separably containing two liquidcomponents of a two-part hardenable compound and for insertablyreceiving a sharp medical instrument to be encapsulated; and meanssupported by said containing means for separating said two liquidcomponents being and responsive to said insertable receipt of said sharpmedical instrument for rupturing, thereby causing mixture of said twocomponents into a hardenable compound that hardens around and therebyencapsulates said sharp medical instrument.
 41. An apparatus forenclosing a medical instrument having a sharp extent, comprising: meansfor holding a first component of a two-part hardenable compound; meansfor separably holding a second component of a two-part hardenablecompound; means between said first component and said second componentfor rupturing upon engagement by said sharp extent of said medicalinstrument to thereby allow said first component and said secondcomponent to mix and thereby harden around a portion of said medicalinstrument; and means separate from said means for holding said firstcomponent and said means for holding said second component forenclosably accommodating said sharp extent of said medical instrument.